| Class 2 Device Recall PolarCath Peripheral Dilatation System | |
Date Initiated by Firm | October 11, 2019 |
Create Date | November 21, 2019 |
Recall Status1 |
Terminated 3 on May 03, 2021 |
Recall Number | Z-0507-2020 |
Recall Event ID |
84134 |
510(K)Number | K152665 |
Product Classification |
Catheter, angioplasty, peripheral, transluminal - Product Code LIT
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Product | The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two concentric, non-compliant balloon systems mounted at the distal tip (balloon within a balloon design). The catheter is available in various working lengths and appropriate balloon diameters and lengths. The balloon has radiopaque markings to assist in balloon placement and to visualize proper expansion of the inflated balloon. The catheter tip is tapered to facilitate entry into peripheral arteries and across lesions. The catheter is designed to be used with appropriately sized guidewires and introducers. |
Code Information |
Lots: CAT 0738, CAT 0739, CAT 0740, CAT 0743, CAT 0744, CAT 0746, CAT 0750, CAT 0751, CAT 0758 |
Recalling Firm/ Manufacturer |
Nucryo Vascular Inc. 2192 Bering Dr San Jose CA 95131-2013
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For Additional Information Contact | 650-279-1653 |
Manufacturer Reason for Recall | Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO sterilized labels. |
FDA Determined Cause 2 | Error in labeling |
Action | On 10/11/19, Field Advisory Notices were mailed to customers informing them to check their inventory and return affected unused product. Further, customers were asked to complete and return the Field Action Response form. Customer service can be contacted at the following number , 408-541-1414. |
Quantity in Commerce | 49 |
Distribution | U.S.: CA, TX, OK, AR, MI, MS.
No foreign (OUS) distribution |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = LIT
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